Sensis Vibe Combo Device Recalled for Software Communication Failure
The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential to impact patient monitoring during critical cardiac procedures. No illnesses or injuries are reported. The software defect prevents vital signs display during procedures, representing significant clinical risk without documented harm, qualifying as a risk-of-harm product without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Sensis Vibe Combo with software version VD12A, a diagnostic and administrative device used to support hemodynamic catheterizations and electrophysiology studies for cardiac and interventional radiology procedures.
The device may experience a communication disconnect during the first patient examination of the day or following extended periods of inactivity. When this occurs, vital signs data becomes unavailable, preventing clinicians from monitoring critical patient parameters during procedures.
The recall affects 13 units distributed across the United States, including Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico, and Texas. Affected serial numbers are identified in the recall documentation provided by Siemens.
Healthcare facilities operating this device should contact Siemens Medical Solutions USA, Inc. for further information regarding this issue.
The recalled product
- Product
- Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-defect
- communication-failure
- vital-signs-unavailable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI-DI: 04056869010205 Serial Numbers: 123021
- 123055
- 123056
- 123058
- 122042
- 123004
- 122006
- 122026
- 122029
- 123047
- 123053
- 122011
- 121014.
Distribution
Distributed nationwide across the United States.
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